Received May 11, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
adverse cardiac event; This is a spontaneous report received from a Consumer or other non HCP. An 8-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (BNT162B2 OMICRON (LP.8.1)), as dose 1, single (Batch/Lot number: unknown) at the age of 8 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (disability), outcome "not recovered", described as "adverse cardiac event". Therapeutic measures were taken as a result of cardiac disorder. Clinical course: Patient's mother reported her daughter experienced adverse cardiac event after receiving the Pfizer mrna vaccine at age 8 and now takes a beta blocker. AE resulted in Disability or permanent damage. Known allergies mentioned as "N/A". Mother stated patient had no health conditions. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.; Sender's Comments: Based on the information available and on the pathophysiology of the event Cardiac disorder there is not enough evidence to reasonably attribute the reported event as related to study vaccine, concomitant drugs, or clinical trial procedure. The event was likely due to subject underlying contributory factors.
Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None